MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST 4.1 HIGH PERFORMANCE; STATIONARY BASIC DIAGNOSTIC X-RAY SYSTEM, DIGITAL

Model Number	DIGITALDIAGNOST 4.1 HIGH PERFORMANCE
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference id: (b)(4).The digitaldiagnost r4.X is a stationary x-ray system for general radiographic purposes.As an option, a portable digital flat panel detector (model "skyplate") can be used for image capture.Philips received a complaint on digitaldiagnost r4.X indicating that the generator error observed after a power outage.The use of device was unknown.The field service engineer (fse) performed analysis and concluded that heavy smoke was observed and the small transformer was severely damaged by burning.Upon reviewing the generator logs, multiple rotor controller errors were identified.A power surge caused the failure of the line filter board.Customer performed replacement of filter board with independently.Investigation in-progress.
Event or Problem Description
It was reported that generator error observed after a power outage.The use of device was unknown.
Additional Manufacturer Narrative
Reference id: (b)(4).The digitaldiagnost r4.X is a stationary x-ray system for general radiographic purposes.As an option, a portable digital flat panel detector (model "skyplate") can be used for image capture.Philips received a complaint on digitaldiagnost r4.X indicating that the generator error observed after a power outage.The use of device was unknown.Based on discussions with the customer, heavy smoke was observed in the room, leading to evacuation and fire department response.The field service engineer (fse) investigated the system and confirmed that the line filter board was severely damaged due to burning.Generator log review showed multiple rotor controller errors.The system was still capable of exposure at the time of the event.The root cause was confirmed to be a facility power surge, which resulted in damage to the line filter board.The customer independently replaced the damaged filter board.The research and development (r&d) team conducted an analysis and concluded the following: the impacted component is ¿line filter board¿ having followed key functions, 1.Emi filtering.2.Surge/high kv protection.As the protection components were observed to be blown, this is considered expected behavior in the event of a high-voltage surge on the input mains lines.After replacing this board, the intended functionality has been restored, and it is safe to continue using the generator.Based on the information available and the testing conducted, the cause of the reported problem was power surge which led to the failure of the line filter board.The reported problem was confirmed by the customer.Updated evaluation results code.Updated (device) problem code grid.Updated conclusion code grid.

• Brand Name: DIGITALDIAGNOST 4.1 HIGH PERFORMANCE
• Common Device Name: STATIONARY BASIC DIAGNOSTIC X-RAY SYSTEM, DIGITAL
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• Manufacturer Contact: dusty leppert ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 23583422
• Report Number: 3003768251-2025-000137
• Device Sequence Number: 18467919
• Product Code: MQB
• UDI-Device Identifier: 00884838065321
• UDI-Public: (01)00884838065321
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DIGITALDIAGNOST 4.1 HIGH PERFORMANCE
• Device Catalogue Number: 712031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown